(266 days)
No
The 510(k) summary describes a mechanical implant system and its associated instrumentation, with performance studies focused on mechanical properties. There is no mention of AI, ML, image processing, or data sets typically associated with AI/ML technologies.
Yes.
The device is intended to treat various medical conditions, including post-traumatic or degenerative arthritis, previously infected arthrosis, and severe deformity or instability, by facilitating tibiotalcaneal arthrodesis (fusion). This aligns with the definition of a therapeutic device designed to treat, cure, mitigate, or prevent disease.
No
This device is a surgical implant (intramedullary nail system) used for tibiotalcaneal arthrodesis (fusion), not for diagnosing medical conditions.
No
The device description explicitly states it consists of implantable intramedullary nails, endcaps, and locking screws made of titanium alloy and PEEK, which are hardware components. It also includes device-specific instrumentation.
Based on the provided information, the Vilex Redemption Duo Hindfoot Nail System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for tibiotalcaneal arthrodesis (fusion), which is a surgical procedure to fuse bones in the ankle and heel. This is a therapeutic intervention, not a diagnostic test performed on samples from the body.
- Device Description: The device consists of implantable intramedullary nails, endcaps, and locking screws. These are physical implants used to stabilize bones during the fusion process. IVD devices are typically reagents, instruments, or systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
- Lack of Diagnostic Elements: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide diagnostic information.
- Performance Studies: The performance studies listed are related to the mechanical properties of the implants (bending fatigue, static torsion, etc.), which are relevant for surgical implants, not diagnostic devices.
In summary, the Vilex Redemption Duo Hindfoot Nail System is a surgical implant used for bone fusion, which falls under the category of medical devices used for treatment, not diagnosis.
N/A
Intended Use / Indications for Use
The Vilex Redemption Duo Hindfoot Nail System is intended for tibiotalcaneal arthrodesis (fusion)
Specific indications include:
- · Post-traumatic or degenerative arthritis
- · Previously infected arthrosis
- · Revision ankle arthrodesis
- Failed total ankle arthroplasty
- · Avascular necrosis of the talus
- · Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
- Rheumatoid arthritis
- · Osteoarthritis
- Pseudarthrosis
- · Trauma (malunited tibial pilon fracture)
- · Charcot foot
- · Severe endstage degenerative arthritis
- Severe defects after tumor resection
- Pantalar arthrodesis
- · Post-traumatic arthrosis
- · Neuroarthropathy
Product codes
HSB
Device Description
The Vilex Redemption Duo system consists of implantable intramedullary nails, endcaps, and locking screws manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136 and PEEK per ASTM F2026) that are implanted into the talocrural region to facilitate tibiotalocalcaneal arthrodesis (fusion). A variety of implant sizes are provided to accommodate individual patient anatomy. The Vilex Redemption Duo system includes device specific instrumentation for use in site preparation, implantation, and removal of the implants and instruments are packaged clean and non-sterile in a sterilization tray with instructions for sterilization prior to surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
talocrural region
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following performance data were provided in support of the substantial equivalence determination:
- Bending Fatigue per ASTM F1264-16e1
- Static Torsion per ASTM F543-17
- Driving Torque per ASTM F543-17
- Removal Torque per ASTM F543-17
- Axial Pullout Strength per ASTM F543-17
- Static Four-Point Bending per ASTM F1264-16e1
- Static Torsion per ASTM F1264-16e1
- Dynamic Four-Point Bending per ASTM F1264-16e1
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
K221031, K051678, K173811, K102413
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.
0
January 30, 2024
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Vilex LLC Brock Johnson President 111 Moffitt Street McMinnville, Tennessee 37110
Re: K231343
Trade/Device Name: Redemption Duo Hindfoot Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: December 21, 2023 Received: December 21, 2023
Dear Brock Johnson:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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Digitally signed by Joseph P. Russell -S Date: 2024.01.30 10:26:04 -05'00'
for: Farzana Sharmin, PhD Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Vilex Redemption Duo Hindfoot Nail System
Indications for Use (Describe)
The Vilex Redemption Duo Hindfoot Nail System is intended for tibiotalcaneal arthrodesis (fusion)
Specific indications include:
- · Post-traumatic or degenerative arthritis
- · Previously infected arthrosis
- · Revision ankle arthrodesis
- Failed total ankle arthroplasty
- · Avascular necrosis of the talus
- · Severe deformity or instability as a result of talipes equinovarus, cerebral vascular accident, paralysis or other neuromuscular disease
- Rheumatoid arthritis
- · Osteoarthritis
- Pseudarthrosis
- · Trauma (malunited tibial pilon fracture)
- · Charcot foot
- · Severe endstage degenerative arthritis
- Severe defects after tumor resection
- Pantalar arthrodesis
- · Post-traumatic arthrosis
- · Neuroarthropathy
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
I. Submitter
Vilex LLC 111 Moffitt Street McMinnville, TN 37110
Contact Person: Brock Johnson, President of Vilex Phone: (801) 916-4157 brock.johnson@vilex.com Date Prepared: 20 April 2023
II. Device
| Device Proprietary Name: | Redemption Duo Hindfoot Nail System |
|---|---|
| Common or Usual Name: | Rod, Fixation, Intramedullary and Accessories |
| Classification Name: | Intramedullary Fixation Rod |
| Regulation Number: | 21 CFR 888.3020 |
| Product Code: | HSB |
| Device Classification | II |
III. Predicate Device
Substantial equivalence is claimed to the following devices:
| Device
Type | 510(k)
Number | Trade Name | Applicant | Product
Code |
|----------------------|------------------|----------------------------------------------------------------|------------------|-----------------|
| Subject
Device | - | Redemption Duo Hindfoot Nail System | Vilex | HSB |
| Primary
Predicate | K091976 | Biomet Phoenix Ankle Nail and Ankle
Arthrodesis Nail | Zimmer
Biomet | HSB |
| Reference
Device | K221031 | Arthrex DualCompression Hindfoot
Fusion Nail Implant System | Arthrex | HSB |
| Reference
Device | K051678 | Synthes Hindfoot Arthrodesis Nail
System | Depuy
Synthes | HSB |
| Reference
Device | K173811 | TRIWAY Tibiotalocalcaneal (TTC)
Arthrodesis System | In2Bones
SAS | HSB
HWC |
| Reference
Device | K102413 | FUZE: Intramedullary Internal Fixation
Nail | Vilex | HSB |
IV. Device Description
The Vilex Redemption Duo system consists of implantable intramedullary nails, endcaps, and locking screws manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136 and PEEK per ASTM F2026) that are implanted into the talocrural region to facilitate tibiotalocalcaneal arthrodesis (fusion). A variety of implant sizes are provided to accommodate individual patient anatomy. The Vilex Redemption Duo system includes device specific instrumentation for use in site preparation, implantation, and removal of the implants and instruments are
4
packaged clean and non-sterile in a sterilization tray with instructions for sterilization prior to surgery.
V. Indications for Use
The Vilex Redemption Duo Hindfoot Nail System is intended for tibiotalocalcaneal arthrodesis (fusion)
Specific indications include:
- Post-traumatic or degenerative arthritis .
- Previously infected arthrosis ●
- Revision ankle arthrodesis .
- Failed total ankle arthroplasty .
- . Avascular necrosis of the talus
- Severe deformity or instability as a result of talipes equinovarus, cerebral vascular . accident, paralysis or other neuromuscular disease
- Rheumatoid arthritis .
- . Osteoarthritis
- Pseudarthrosis .
- Trauma (malunited tibial pilon fracture) .
- Charcot foot ●
- Severe endstage degenerative arthritis .
- Severe defects after tumor resection .
- Pantalar arthrodesis ●
- Post-traumatic arthrosis ●
- Neuroarthropathy .
VI. Comparison of Technological Characteristics with the Predicate Devices
The subject and predicate devices have similar intended uses and share identical core characteristics. The subject and predicate devices are implanted into the talocrural region to facilitate tibiotalocalcaneal arthrodesis (fusion). At a high level, the subject and predicate devices share the following technological characteristics:
- Product code
- Indications for Use
- Principles of Operation ●
- Material of construction ●
- Nail lengths ●
- Nail diameters ●
- Cap lengths
- Screw lengths
- Screw diameter ●
- Sterilization method
The technological differences between the subject device and predicate devices include minor dimensional differences and differences in raw material and sterilization method. These changes are
5
considered minor and do not raise different questions of safety or effectiveness and substantial equivalence is demonstrated through the testing described below.
VII. Performance Data
The following performance data were provided in support of the substantial equivalence determination:
- Bending Fatigue per ASTM F1264-16e1 ●
- Static Torsion per ASTM F543-17
- Driving Torque per ASTM F543-17
- Removal Torque per ASTM F543-17
- Axial Pullout Strength per ASTM F543-17 ●
- Static Four-Point Bending per ASTM F1264-16e1 ●
- Static Torsion per ASTM F1264-16e1
- Dynamic Four-Point Bending per ASTM F1264-16e1 ●
VIII. Conclusion
The information provided above supports that the Vilex Redemption Duo Hindfoot Nail System is as safe and effective as the predicate device. Although minor differences in the design exist between the subject and predicate devices, the testing supports that these differences do not raise any different questions of safety and effectiveness. Therefore, it is concluded that the Vilex Redemption Duo Hindfoot Nail System is substantially equivalent to the predicate device.